Have your say on TGA fast tracks

By The Australian Regulatory Review Survey Team 3 years ago | In Industry, Regulatory
  • 3 years ago

The Australian Regulatory Review Survey Team (Alina Yoffe, adjunct Associate Professor Orin Chisholm, Dr Greg Smith, Dr Johnson Liu) from UNSW is researching Australia’s accelerated review pathways and is looking for feedback.

Accelerated regulatory approval pathways in Australia are proving to be of vital importance, particularly in the time of the COVID-19 pandemic. Both the AstraZeneca and the Pfizer vaccines were provisionally approved through one such accelerated pathway – the Provisional Approval pathway.

It took only 55 TGA working days to approve Pfizer’s COMIRNATY mRNA vaccine on 25 January 2021, and only 48 days to approve the COVID-19 vaccine AstraZeneca on 15 February 2021. This is compared to a mean of 182 TGA working days for approval of prescription medicines in 2020 via the standard pathway.

Both vaccines were provisionally approved based on preliminary clinical data, not a full data set dossier. If it wasn’t for the Provisional Approval accelerated pathway, we would likely not have the vaccines in Australia so early in their clinical development and within such rapid approval timelines.

The accelerated pathways were introduced in Australia as a result of the Review of Medicines and Medical Devices Regulation – a major Regulatory reform that started in 2014.

This reform aimed to remove inefficient and duplicate regulation, increase the flexibility of the regulatory system, simplify compliance and reduce costs to business, align with other National Regulatory Authorities globally and boost the competitiveness of Australia.

The Priority Review prescription medicine registration pathway was introduced in June 2017 and the Provisional Approval pathway in March 2018. The number of medicines going through them is increasing each year. Both are intended for serious and life-threatening diseases.

UNSW researchers are conducting a project to study and analyse the accelerated pathways, which have implications for patient safety and outcomes, clinical guidelines and practice, health policy, pricing and reimbursement.

The project involves a short anonymous online survey of regulatory affairs professionals to gather their perspectives on utilisation of the new accelerated pathways available to them in Australia. We’ve included the invite and link to the survey below. Please read and have your say!

Invitation to Participate in Research

Research Study Title: Analysis of the impact of the new accelerated regulatory approval pathways on access to new medicines in Australia

Researchers at UNSW are conducting a project about the Priority Review and Provisional Approval medicine registration pathways introduced in Australia in the past few years. The research project is looking to recruit people who want to take part in this research and who have experience in submission of application(s) for registration of medicine(s) using at least one of the following pathways: standard application, Priority Review or Provisional Approval.

Participants who do not have such experience will not be included in the study. Your decision to take part is optional and voluntary and the survey is anonymous.

It will take approximately 10-20 minutes to complete the survey. If you would like to take part in this research, you can do so by clicking here. The survey is preceded by the Participant Information Statement containing further information on the research project, activities and contact information. At the end of the statement, you’ll have a choice to either proceed or leave.

Click here to link to survey or alternatively, paste the following into your browser: https://unsw.au1.qualtrics.com/jfe/form/SV_cGrEnsMpyeFj36Z

The Australian Regulatory Review Survey Team

©MedNews 2021

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